FDA Clears Medrad Intego for Use in PET Imaging

July 7, 2010 – The U.S. Food and Drug Administration (FDA) has granted Medrad Inc. clearance to market the Medrad Intego positron emission tomography (PET) infusion system for sodium fluoride (F18-NaF) administration in PET imaging. F18-NaF PET is most frequently used in oncology to find and assess bone metastases.

With its rapid uptake in the bone and quick bone clearance, there is growing clinical evidence of the value of F18-NaF as an effective diagnostic imaging agent in bone cancer imaging. PET technology provides high-resolution images that may be quantified for detailed and comparative analysis. It is these benefits, in part, that led the Center for Medicare and Medicaid Services (CMS) to announce plans in February 2010 to cover F18-NaF PET imaging for beneficiaries under a Coverage with Evidence Development program.

Receiving FDA clearance for F18 fluorodeoxyglucose (F18-FDG) administration in 2008, Intego is the only multi-PET agent infusion system currently cleared by the FDA. The system is loaded with a multidose vial, and nuclear medicine technologists can dose on demand from a touch screen to enable precise, flexible, safe and efficient administration of PET agents.

Medrad Intego systems are in place in hospitals and clinics throughout the U.S., Europe, Australia and the Middle East.

Prototype fluidic system for zirconium-89 purification. Image taken through a hot cell window at the Department of Radiology, University of Washington. Image courtesy of Matthew O’Hara, Pacific Northwest National Laboratory